Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, updated its communication regarding the withdrawal of its application for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) for the SARS-CoV-2 molecular diagnostic test on its Revogene® platform.
In subsequent communication with the FDA mid-morning on February 23, 2021, the FDA clarified that Meridian will not be able to distribute its SARS-CoV-2 molecular diagnostic test on its Revogene® platform until the test receives EUA approval from the FDA. This corrects the Company’s prior statement that the Company would resume shipping the Revogene® SARS-CoV-2 test to customers upon notification of its intent to re-submit an EUA application.
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